Focused ultrasound is cleared to treat liver tumors in the United States.
The US Food and Drug Administration (FDA) has cleared HistoSonics’ novel therapy platform – called EdisonTM – to treat liver tumors. EdisonTM uses histotripsy to noninvasively destroy tissue in the liver and is the first and only such platform available in the US. This is also the first time the use of histotripsy has earned regulatory approval worldwide. Read More
Focused Ultrasound Therapy
Focused ultrasound is a rapidly evolving, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with liver tumors. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
How it Works
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated.
One mechanism is the production of precise ablation (thermal destruction of tissue). This destruction can be done to completely destroy the target or to partially treat it, and partial treatment is believed to stimulate the patient’s immune response, which may have a broader impact.
Another mechanism is the use of mechanical (non-thermal) histotripsy to destroy the tumor.
A third mechanism is to use focused ultrasound to cause hyperthermia which enables the local release and absorption of a therapeutic that is contained in the blood stream.
A fourth mechanism is to use Boiling Histotripsy to destroy the targets in the liver. This has the advantage that it may be useful as a ‘bridging’ technique to treat the patient and may also help in the regrowth of non-fibrous tissue, as the patient is waiting for a liver transplant. While this has had success in animal models, it has not yet been transferred to human treatment.
Advantages
The primary options for treatment of liver tumors include surgery, chemotherapy, radiotherapy, localized destruction of the tumor tissue (via radiofrequency ablation, alcohol injection, cryosurgery, or laser photocoagulation), or combination of two or more of these options. The long-term solution for primary liver cancer is often liver transplantation.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. Focused ultrasound can also enhance the chemotherapy dose for the target, with less impact to the rest of the patient.
Clinical Trials
A clinical trial in the UK is recruiting patients with colorectal cancer and metastasis to the liver. It uses focused ultrasound to activate a microbubble preparation designed to improve the penetration of chemotherapy to the liver.
An observational clinical trial is being done on patients treated with the Histosonics’ Edison device looking for long term outcomes for the patients treated.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
See a list of treatment sites >
See a list of laboratory research sites >
Regulatory Approval and Reimbursement
In October 2023, the US Food and Drug Administration cleared HistoSonics’ Edison device to noninvasively treat liver tumors using histotripsy.
A focused ultrasound system has been approved in China, Russia, Europe, and Korea for treatment of liver cancer.
To the best of our knowledge, the use of focused ultrasound to treat liver cancer is not yet widely reimbursed by medical insurance.
Notable Papers
Wehrle CJ, Burns K, Ong E, Couillard A, Parikh ND, Caoili E, Kim J, Aucejo F, Schlegel A, Knott E, Laeseke P, Boudreaux JP, von Breitenbuch P, Silk M, Alassas M, Guzowski A, Fuller B, Koepsel EK, Hewitt B, Mendiratta-Lala M, Kwon CD. The First International Experience with Histotripsy: A Safety Analysis of 230 Cases. J Gastrointest Surg. 2025 Feb 18:102000. doi: 10.1016/j.gassur.2025.102000. PMID: 39978577
Uysal M, Wehrle CJ, Coppa C, Kamath S, Krishnamurthi S, Martin C, Hag ME, Khalil M, Fujiki M, Schlegel A, Miller C, Hashimoto K, Aucejo F, Kwon DC, Kim J. Bridging therapy with histotripsy prior to liver transplantation for hepatocellular carcinoma: a first case report. Exp Hematol Oncol. 2025 Feb 25;14(1):20. doi: 10.1186/s40164-025-00604-z. PMID: 40001149
Liao Y, Wang D, Yang X, Ni L, Lin B, Zhang Y, Feng G, Li J, Gao F, Liao M, Du X, Chen W. Highintensity focused ultrasound thermal ablation boosts the efficacy of immune checkpoint inhibitors in advanced cancers with liver metastases: A singlecenter retrospective cohort study. Oncol Lett. 2025 Jan 7;29(3):124. doi: 10.3892/ol.2025.14871. eCollection 2025 Mar. PMID: 39807097
Li H, Deng Q, Cai Z, Wang Q, Huang L, Gao Y, Dong X, Sun L, Liu Z. Ultrasound Erosion of Rabbit Liver Induced by Locally Injected Phase-Shift Acoustic Droplets and With Lauromacrogol. J Ultrasound Med. 2025 Jan 21. doi: 10.1002/jum.16650. PMID: 39835387
Dai Q, Xu LX, Zhang A, Fowlkes JB. Study of Histotripsy With Subsequent Heating on In Vitro VX2 Cancer Cells. J Ultrasound Med. 2025 Jan 22. doi: 10.1002/jum.16649. PMID: 39840594
Cheung WS, She WH, Tsang SHY, Dai WC, Chan ACY, Cheung TT. Comparison of radiofrequency ablation, microwave ablation and high-intensity focused ultrasound for hepatocellular carcinoma: a retrospective study. HPB (Oxford). 2025 Jan 7:S1365-182X(25)00003-6. doi: 10.1016/j.hpb.2025.01.003. PMID: 39843271
Yang J, Liao M, Wu Z, Liu X, Zheng Z, Wang W, Wu Z, Lu Q. Perfluorohexane Nanodroplet-Assisted Mechanical High Intensity Focused Ultrasound Cavitation: A Strategy for Hepatocellular Carcinoma Treatment. Acta Biomater. 2025 Jan 31:S1742-7061(25)00081-9. doi: 10.1016/j.actbio.2025.01.061. PMID: 39894325
Cambronero S, Dupré A, Mastier C, Chen Y, Hamelin O, Melodelima D. Intraoperative HIFU ablation of the liver at the hepatocaval confluence as adjunct to surgery: Preliminary animal experiments. Ultrasonics. 2024 Dec 20;148:107556. doi: 10.1016/j.ultras.2024.107556. PMID: 39719790
Rog CJ, Alassas M, Ong E. Histotripsy-A Novel and Intriguing Technique of Liver Ablation. JAMA Surg. 2024 Nov 20. doi: 10.1001/jamasurg.2024.2339. PMID: 39565600
Ambekar PA, Wang YN, Khokhlova T, Thomas G, Rosnitskiy P, Contreras K, Leotta DF, Maxwell AD, Bruce M, Pierson S, Totten S, Kumar YN, Thiel J, Chan K, Conrad Liles W, Dellinger EP, Adedipe A, Monsky W, Matula TJ. Histotripsy-induced bactericidal activity correlates to size of cavitation cloud in vitro. IEEE Trans Ultrason Ferroelectr Freq Control. 2024 Oct 9;PP. doi: 10.1109/TUFFC.2024.3476438. PMID: 39383065
Xiong X, Zhou H, Xu X, Fu Q, Wan Y, Cao Y, Tang R, Li F, Zhang J, Li P. Ultrasound Molecular Imaging Enhances High-Intensity Focused Ultrasound Ablation on Liver Cancer With B7-H3-Targeted Microbubbles. Cancer Med. 2024 Oct;13(20):e70341. doi: 10.1002/cam4.70341. PMID: 39431644
Ruger L, Langman M, Farrell R, Rossmeisl JH, Prada F, Vlaisavljevich E. Ultrasound-Guided Mechanical High-Intensity Focused Ultrasound (Histotripsy) Through an Acoustically Permeable Polyolefin-Based Cranioplasty Device. IEEE Trans Biomed Eng. 2024 Oct;71(10):2877-2888. doi: 10.1109/TBME.2024.3399688. Epub 2024 Sep 19. PMID: 38728123
Mendiratta-Lala M, Wiggermann P, Pech M, Serres-Créixams X, White SB, Davis C, Ahmed O, Parikh ND, Planert M, Thormann M, Xu Z, Collins Z, Narayanan G, Torzilli G, Cho C, Littler P, Wah TM, Solbiati L, Ziemlewicz TJ. The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors. Radiology. 2024 Sep;312(3):e233051. doi: 10.1148/radiol.233051. PMID: 39225612
Click here for additional references from PubMed.
Video courtesy of Insightec.